Heart and Blood Diseases

All Conditions

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Substance Related Disorders

Wounds and Injuries

Nervous System Diseases

Heart Failure

Cardiotoxicity

Autonomic Nervous System Diseases

Primary Dysautonomias

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

A group of patients who will not be trained will be evaluated at baseline (pre) and after 16 weeks.

They are oriented to maintain lifestyle changes

Patients will complete 16 weeks of training including 40 minutes of aerobic training, 15 minutes of resistive exercise and 5 minutes of relaxation.

Patients undergo 16 weeks of physical training

exercise training

Amanda Gonzales Rodrigues

Carlos Eduardo Negrao, PHD

Roberto Kalil Filho, PHD

New therapies for cancer increased patient survival, but led to the recognition of adverse effects associated with cancer treatment, such as the use of chemotherapy. Cardiotoxicity is the most significant adverse effect, which affect the functional capacity and quality of life and is associated with high morbidity and mortality, regardless of the oncological prognosis. One of the manifestations of cardiotoxicity is ventricular dysfunction that can lead to heart failure. Neuro humoral hyperactivation with increased sympathetic nerve activity is a typical manifestation of heart failure and is associated with worse prognosis. Studies have shown that physical training significantly reduces sympathetic nerve activity in addition to improving muscle blood flow, reversing effects on skeletal muscle and improving quality of life. The hypothesis is that physical training may reduce sympathetic nerve activity and vasoconstrictor status in patients with heart failure caused by anthracyclines, as well as improving baroreflex and chemoreflex sensibility, mechanoreflex and metaborreflex control and skeletal myopathy.

The investigators included patients\> 18 years, left ventricular ejection fraction \<= 0.55, functional class (NYHA) I-III, under medical treatment for heart failure. Patients with coronary artery disease, moderate to severe valve disease, positive Chagas serology, inability to participate in an exercise program are excluded.

Primary outcome: Muscle sympathetic nerve activity Secondary outcome: arterial baroreflex sensitivity, peripheral chemorreflex sensitivity, mecanic and muscuclar metaborreflex control, ubiquitin proteasome system activity.

Patients were divided into 2 groups-trained (n = 10) and non-trained (n = 10). Patients in the trained group will complete 16 weeks of aerobic training. Evaluation of cardiac function, functional capacity, quality of life and biochemical evaluation (troponin, hs-CRP and BNP). For muscle evaluation will be performed biopsy of the vastus lateralis muscle

Effect of Physical Training in Patients With Heart Failure Caused by Chemotherapy for Cancer Treatment

The sympathetic nervous activity is assessed by the microneurography technique

Evaluation of muscular sympathetic nervous activity at rest by the technique of microneurography, evaluation of the muscular blood flow by venous occlusion plethysmography technique

InCor Heart Institute

Cancer Institute of Sao Paulo

Hospital Sirio-Libanes

University of Sao Paulo General Hospital

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Kidney Diseases

Hypertension

Prostatic Neoplasms

Vascular Diseases

Antineoplastic Agents

Reproductive Control Agents

Androgens

Hormones

Leuprolide

Goserelin

Bicalutamide

Flutamide

Androgen Receptor Antagonists

Hormone Antagonists

Antineoplastic Agents, Hormonal

Androgen Antagonists

Men undergoing androgen deprivation therapy via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for the treatment of prostate cancer

Healthy men undergoing gonadal suppression via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for 9 weeks

Healthy men undergoing placebo for 9 weeks.

Gonadotropin-Releasing Hormone Agonist

Androgen receptor inhibitor

Placebo

Matthew Babcock, PhD

This study plans to learn more about contributors to high blood pressure in men who undergo androgen deprivation therapy (ADT) to treat prostate cancer. Prostate cancer is the most common non-skin cancer in men, affecting approximately 1 in 8 American men and its primary treatment is through the use of ADT. However, ADT increases the likelihood of developing heart disease including high blood pressure. This study will determine if dysfunction of the nervous system and/or kidneys occurs in men undergoing ADT, as these systems play a significant role in control of blood pressure. The results from this study will help us understand the ways in which ADT contributes to heart disease and help us develop therapies to prevent heart disease in prostate cancer survivors.

Contributions to Hypertension With Androgen Deprivation Therapy

Autonomic and Renal Contributions to Hypertension With Androgen Deprivation Therapy

Proteomic analysis of inflammatory cascade proteins will be quantified in plasma samples.

Whole blood reactive oxygen species will be measured in from venous blood samples using electron paramagnetic resonance spectroscopy

Descriptive variable total body fat mass (for screening and to document any changes with the intervention)

The change in cardiovagal baroreflex sensitivity will be assessed the modified Oxford procedure

The change in blood pressure will be assessed from quiet rest to sympathetic activation using the cold pressor test

The change in blood pressure will be assessed from quiet rest to isometric handgrip exercise

Ambulatory blood pressure variability will be determined from 24-hour ambulatory blood pressure monitoring.

Beat-to-beat blood pressure variability will be using finger photoplethysmography measured in the laboratory.

Renal blood flow will be determined using ultrasound and blood pressure will be determined using finger photoplethysmography. These measures will be used to estimate renal vascular resistance.

Neutrophil gelatinase-associated lipocalin (NGAL), kidney injury molecule (KIM)-1, interleukin (IL)-18, and vanin-1 will be quantified in urine using commercially available assay kits. Concentrations will be normalized to urinary flow rate.

Changes in muscle sympathetic nerve activity in response to changes in blood pressure will be assessed using the modified Oxford procedure

The change in muscle sympathetic nerve activity will be assessed from quiet rest to sympathetic activation using the cold pressor test.

Glomerular filtration rate and renal plasma flow will be calculated by iohexol (Omnipaque 300, GE Healthcare) clearance technique. Plasma and urine iohexol and p-aminohippurate clearance will be measured on a High-Performance Liquid Chromatography (HPLC, Waters, Milford, MA).

Renal plasma flow will be calculated by p-aminohippurate (Basic Pharma) clearance techniques. Plasma and urine p-aminohippurate clearance will be measured on a High-Performance Liquid Chromatography (HPLC, Waters, Milford, MA).

University of Colorado, Denver

Skin and Connective Tissue Diseases

Nutritional and Metabolic Diseases

Breast Neoplasms

Metabolic Syndrome

Syndrome

Metabolic Diseases

Lipid Metabolism Disorders

Insulin Resistance

Hyperinsulinism

Glucose Metabolism Disorders

Menopause

Two cohorts of both healthy postmenopausal women and women free of postmenopausal breast cancer recurrence. Each of the groups will be split into two different exercise programmes. Both programmes, High Intensity Interval Training (HIIT) programme (metabolic power training) and Muscle Power Intervention (MPI) programme will consist of 8 weeks.

Two cohorts of both healthy postmenopausal women and women free of postmenopausal breast cancer recurrence.

Metabolic Power Training: A High Intensity Interval Training (HIIT) intervention, 3 times per week (30 min session) during 8 weeks with professional supervision and intensities adapted and modified during the intervention period.

HIIT program (8 weeks)

Muscle Power Intervention (MPI), 2 times per week (45 min session) during 8 weeks with professional supervision and intensities adapted and modified during the intervention period.

MPI program (8 weeks)

Cristina Blasco Lafarga, Tenured Professor

Cristina Blasco Lafarga, PhD

Jordi Monferrer-Marín, Predoctoral student

Ainoa Roldán, PhD

Jørn Wulff Helge, PhD

POWER Health is a randomized clinical trial with a two-arm parallel design whose objectives are 1) to study metabolic flexibility and autonomic function (both capacities that describe cardiovascular health) in a sample of postmenopausal oncological women vs postmenopausal untreated controls (CT); and 2) to analyze the impact of two different 8-week physical exercise supervised interventions: HIIT training vs strength training focused on muscle power, on both cardiovascular capacities in these populations.

Nowadays, breast cancer is the most common type of cancer worldwide, accounting for 30% of all cancers in Spanish women in 2023. Cancer is also the second leading cause of death in developed countries, following cardiovascular diseases, with which it shares a close relationship. Additionally, we know that the incidence of breast cancer increases with age, experiencing a rise after menopause. However, lifestyle and physical exercise are known to improve the prevention, prognosis, and survival of this disease, as well as enhance quality of life in these patients. Indeed, recent studies have highlighted the relevance of cardiovascular health in this oncological process, as well as the potential of physical exercise interventions to improve cardiovascular health following the disease.

POWER Health is a randomized clinical trial aimed at studying metabolic flexibility and autonomic health in a population of breast cancer recurrence-free women (RFC) compared to postmenopausal untreated controls (CT), along with the implementation of two supervised exercise interventions in both populations. These interventions will last for 8 weeks, one involving HIIT exercise focused on improving metabolic power (MPI), and the other one involving strength exercise focused on enhancing muscular power, with the hypothesis of better metabolic flexibility and autonomic function, and consequently, better cardiovascular health.

POWER health is a mixed method design: cross-sectional \& longitudinal study. Given the feasibility and simple application of POWER Health, this clinical trial will contribute to the prevention and improvement of the health of postmenopausal women, with an important clinical and economic impact, not only in the scientific community but also in clinical practice.

Metabolic Flexibility and Autonomic Control After Muscle Power vs Metabolic Power Training in Postmenopausal Oncological Women: the POWER Health Study

Postmenopausal Oncological Women Exercising for Recover Their Health. Associations and Changes in Metabolic Flexibility and Autonomic Control After Two Training Programs (Muscle Power vs Metabolic Power): the POWER Health Study

Fat oxidation rates calculated from VO2 and VCO2 values collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) and after applying Frayn's stoichiometric formulae, during an incremental test from 0.45 W/kg with 0.15W/kg each 4-min step

Non-linear mathematical variable that allows collecting physiological information and vagal activity of the organism, analysed in 2-minute intervals by Kubios Scientific software (Kuopio, Finland), during the incremental test

Calf, waist and hip circumferences will be assessed with an anthropometric tape measure (cm)

Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)

The investigators will also assess systolic and diastolic blood pressure in the left (whenever possible) arm at rest.

The investigators will also assess oxygen saturation in middle finger of the right hand at rest.

The SARC-F will be used to evaluate the risk of sarcopenia

The International Physical Activity Questionnaire (IPAQ) will be used to evaluate the current physical activity level of the participants. Minimum value = 0 min/day of physical activity // Maximum value = 1440 min/day of physical activity. Higher scores imply a more physically active pattern.

Lactate assessment will be obtained by lactate analyzer (Lactate Scout Sport SensLab GmbH, Leipzig, Germany)

The Rating Perceived Exertion (RPE) of Borg scale will be used to obtain the perceived effort. Minimum value: 1 // Maximum value: 10. Higher scores mean a worse outcome.

The Visual Analogue Scale of Pain (VAS) scale will be used to obtain the local pain assessment. Minimum value: 1 // Maximum value: 10. Higher scores mean a worse outcome.

Cadence will be monitorized by the smart roller Saris H3 (CycleOps Hammer Direct Drive Trainer, Saris, Madison, USA).

Power will be monitorized by the smart roller Saris H3 (CycleOps Hammer Direct Drive Trainer, Saris, Madison, USA).

Power will be calculated by Power Frail App (Toledo, Spain)

Metabolic rate will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions

Resting exchange ratio will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions

Fat oxidation will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions

Carbohydrate will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions

Carbohydrate oxidation rates will be calculated from VO2 and VCO2 values collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) and after applying Frayn's stoichiometric formulae, during an incremental test from 0.45 W/kg with 0.15W/kg each 4-min step

Energy expenditure rate will be calculated will be collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) during an incremental test

FATmax will be calculated will be collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) during an incremental test

VO2peak will be calculated will be collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) during an incremental test

Non-linear mathematical variable that allows collecting physiological information and parasympathetic activity of the organism, analysed in 3-minute intervals by Kubios Scientific software (Kuopio, Finland), during the incremental test

Linear mathematical variable that allows collecting physiological information and parasympathetic activity of the organism, analysed in 2-minute intervals by Kubios Scientific software (Kuopio, Finland), during the incremental test

Generalitat Valenciana

University of Valencia

Senior Lecturer

Gland and Hormone Related Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Thrombosis

Polycystic Ovary Syndrome

Hyperandrogenism

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Disorders of Sex Development

46, XX Disorders of Sex Development

Congenital Abnormalities

Urogenital Abnormalities

Adrenal Hyperplasia, Congenital

Adrenogenital Syndrome

Male Urogenital Diseases

Congenital Adrenal Hyperplasia

21-hydroxylase Deficiency

Hypoglycemic Agents

Micronutrients

Insulin

Insulin, Globin Zinc

Iron

Ethinyl Estradiol

Contraceptive Agents

Contraceptives, Oral

Contraceptives, Oral, Combined

Cyproterone Acetate

Cyproterone

Estradiol

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Polyestradiol phosphate

Contraceptives, Oral, Hormonal

Contraceptive Agents, Female

Contraceptive Agents, Hormonal

Estrogens

Contraceptive Agents, Male

Premenopausal women with functional hyperandrogenism under combined oral contraceptive pill qd as usual clinical practice who will undergo a scheduled standard phlebotomy every 3 months from month 3 to 12 of follow-up.

Premenopausal women with functional hyperandrogenism under standard combined oral contraceptive pill qd as usual clinical practice.

Scheduled standard phlebotomy every three months from month 3 to 12 of follow-up.

Phlebotomy

35 mcg ethinylestradiol qd for 21 days per month as usual clinical practice.

ethinylestradiol

2 mg cyproterone acetate qd for 21 days per month as usual clinical practice.

Manuel Luque Ramírez, M.D., Ph.D.

AIMS To study the effects of the decrease in iron tissue depots after scheduled bloodletting on insulin sensitivity, carbohydrate metabolism, classic and non-classic cardiovascular risk factors in patients with functional hyperandrogenism (polycystic ovary syndrome \& idiopathic hyperandrogenism) on standard treatment with combined oral contraceptives (COC) according to usual clinical practice.

METHODOLOGY

Open label, controlled, parallel, prospective study of 12 months of duration, with 2 randomized arms of follow-up:

i) Intervention Group: Patients with functional hyperandrogenism on standard COC treatment randomly allocated to perform scheduled phlebotomies from the third month of treatment to the end of the study (3 times with a 3-month interval between them).

ii) Control Group: Patients with functional hyperandrogenism on standard COC treatment randomly allocated to follow-up without bloodletting.

The whole group of patients will undergo a comprehensive anthropometric and hormonal assessment, evaluation of classic cardiovascular risk factors (insulin sensitivity and carbohydrate metabolism after a standard oral glucose test- 75 g), lipid profile, ambulatory and office blood pressure monitoring, proinflammatory profile, oxidative stress status, autonomic function assessment, and iron-related metabolism parameters at baseline, after 3-month COC treatment and after reduction of iron tissue depots plus OC in the Intervention Group of patients, and throughout follow-up under treatment with COC in the Control Group of patients. If a significant relationship between circulating hepcidin levels and elevated ferritin concentrations is observed, a study of the potential influence of mutations/polymorphic variants of hepcidin gene on ferritin values will be performed as well.

Phlebotomy and Polycystic Ovary Syndrome

Effect of Decreasing Iron Tissue Depots on the Cardiovascular Risk of Women With Polycystic Ovary Syndrome

All data sets generated during and/or analyzed during the current study are not publicly available but are available from the corresponding author on reasonable request.

Instituto de Salud Carlos III

Manuel Luque Ramírez

Member of the Diabetes, Obesity and Human Reproduction Research Group, Centro de Investigación Biomédica en Red Diabetes y Enfermedades Metabólicas Asociadas CIBERDEM.

Those who meet the Eligibility Criteria will be asked to complete online questionnaires and wear a device on your wrist for two weeks that measures your heart rate, physical activity, and sleep. A WHOOP® wrist monitor and charging equipment will be used.

Kirsten Ness, PhD

This study is being done to evaluate heart rate activity and sleep patterns, among participants in the Long-Term Follow-Up (LTFU) study.

Primary Objective

Using mobile health (mHealth) technologies in a large and well-characterized cohort of childhood cancer survivors, our primary objective is to understand the magnitude of increased risk of cardiac autonomic dysfunction by (a) comparing prevalence rates among survivors and siblings, and (b) determining the prevalence within specific subgroups of childhood cancer survivors defined by race, sex, cancer type and treatment exposures, and type and severity of chronic health conditions.

Secondary Objectives

Among long-term (≥5 years) survivors of childhood cancer (a) identify demographic, disease, treatment and cognitive-behavioral factors associated with an increased risk of cardiac autonomic dysfunction, (b) develop and validate risk prediction models for future clinical use in identifying individuals who may benefit from targeted interventions, and (c) investigate associations between dysfunction and perceived well-being.

Potential participants will be recruited by email and phone. Survivors who wish to participate will complete an online consent form and then a series of short questionnaires to determine study eligibility. This data collection will take place in DatStat Connect, which is the online consenting and data collection tool utilized for the CCSS. Consented/enrolled SJLIFE participants will receive a link via email to complete surveys related to autonomic functioning and current medical concerns and asked to schedule delivery of a WHOOP® strap prior kit prior to scheduling a device setup session with a team member. The kit will include the WHOOP® strap, brief instructions for setup, and prepaid return mailing materials. The WHOOP® strap will be shipped to the participant and each participant will complete a training session and app installation, if needed, and instructions regarding during of wear (two weeks)

Cardiac Autonomic Dysfunction in Childhood Cancer Survivors

Standard deviation of NN (normal to normal RR) intervals (SDNN)

Self-reported autonomic symptoms via the COMPASS31

Self-reported perceived health via Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Physical Training in Patients With Heart Failure Caused by Chemotherapy for Cancer Treatment	NCT04047901	Insufficiency;C... Cancer Cardiotoxicity Heart Failure	exercise traini...	18 Years -	University of Sao Paulo General Hospital
Contributions to Hypertension With Androgen Deprivation Therapy	NCT05700903	Androgen Depriv... Prostate Cancer Hypertension Autonomic Dysfu... Renal Disease	Gonadotropin-Re... Androgen recept... Placebo	40 Years -	University of Colorado, Denver
Metabolic Flexibility and Autonomic Control After Muscle Power vs Metabolic Power Training in Postmenopausal Oncological Women: the POWER Health Study	NCT06336070	Breast Cancer F... Cardiometabolic... Metabolism Diso... Autonomic Dysfu... Cardiovascular ...	HIIT program (8... MPI program (8 ...	35 Years - 75 Years	University of Valencia
Metabolic Flexibility and Autonomic Control After Muscle Power vs Metabolic Power Training in Postmenopausal Oncological Women: the POWER Health Study	NCT06336070	Breast Cancer F... Cardiometabolic... Metabolism Diso... Autonomic Dysfu... Cardiovascular ...	HIIT program (8... MPI program (8 ...	35 Years - 75 Years	University of Valencia
Phlebotomy and Polycystic Ovary Syndrome	NCT02460445	Hyperandrogenis... Metabolic Cardi...	Phlebotomy ethinylestradio... Cyproterone Ace...	18 Years - 45 Years	Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Cardiac Autonomic Dysfunction in Childhood Cancer Survivors	NCT05132673	Autonomic Dysfu... Childhood Cance...		18 Years -	St. Jude Children's Research Hospital
Contributions to Hypertension With Androgen Deprivation Therapy	NCT05700903	Androgen Depriv... Prostate Cancer Hypertension Autonomic Dysfu... Renal Disease	Gonadotropin-Re... Androgen recept... Placebo	40 Years -	University of Colorado, Denver
Effect of Physical Training in Patients With Heart Failure Caused by Chemotherapy for Cancer Treatment	NCT04047901	Insufficiency;C... Cancer Cardiotoxicity Heart Failure	exercise traini...	18 Years -	University of Sao Paulo General Hospital

Spots Global Cancer Trial Database for autonomic dysfunction