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Albuterol

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Arginine

Licorice

Subjects with primary or secondary hypertension and normotensive control subjects. In addition haemodynamic recordings to 50 subjects suffering from chronic fatigue syndrome will be performed.

Subjects who had voluntarily decided to participate in a professionally coached marathon school (Varala Sports Institute, Tampere) were given the chance for haemodynamic recordings before, during and after the training protocol.

Normotensive subjects, daily liquorice ingestion (daily glycyrrhizin dose 290-370 mg) for 2 weeks, haemodynamic measurements before and after the intervention.

Daily ingestion of yoghurt containing small milk casein-derived polypeptides for 12 weeks versus placebo yoghurt.

Hypertensive subjects, bisoprolol 5 mg once daily versus placebo in a double-blind, cross-over protocol.

Subjects with aortic stenosis confirmed by echocardiography

35 normotensive subjects who received research drugs (nitroglycerin, salbutamol, placebo resoriblet, placebo inhalation, L-arginine infusion, saline infusion) in a placebo-controlled, double-blinded manner

Altogether 80 athletes participating in a full length Ironman competition. Non-invasive recordingds are performed under normal conditions during the training period and after completion of a full-length Ironman competition.

From the beginning of the study until the end of year 2016 a single dose of sublingual nitroglycerin was given to examine the associated acute haemodynamic effects (recordings completed).

Nitroglycerin 0.25 mg (single dose, no longer given since January 2017)

From the beginning of the study until the end of year 2016 a 400 µg dose of inhaled salbutamol was given to examine the associated acute haemodynamic effects (recordings completed).

Salbutamol 400 µg (single dose, no longer given since January 2017)

From the beginning of the study until the end of year 2016 L-arginine infusion 10 mg/kg/min could be given for 10 minutes to examine acute haemodynamic effects (recordings completed).

L-arginine (10 min infusion, no longer given since January 2017)

Daily liquorice intake (daily glycyrrhizin dose 290-370 mg) for two weeks, measurements before and after intervention (recordings completed).

Liquorice (2 weeks, glycyrrhizin 290-370 mg daily, no longer given since 2012)

Daily intake of yoghurt containing small milk casein-derived polypeptides (12 weeks) and placebo yoghurt (12 weeks), measurements before and after intervention (recordings completed 2011).

Small milk casein-derived polypeptides (12 weeks daily, recordings completed 2011)

Bisoprolol 5 mg daily for 3 weeks and placebo tablet daily for 3 weeks, double-blind, randomized, placebo-controlled cross-over protocol. Measurements before and after interventions (recordings completed 2011).

Bisoprolol (5 mg daily for 3 weeks, recordings completed 2011)

Ilkka H Pörsti, MD, PhD, Professor

Elina J Hautaniemi, PhD

Ilkka Pörsti, Professor

Ilkka H Pörsti, Professor

Ilkka Pörsti, MD, PhD, Professor

Ilkka Pörsti, MD, PhD

The primary aim of the present study was to examine the haemodynamic changes in primary hypertension and secondary hypertension (renal diseases, endocrine diseases, obesity-associated hypertension) with a non-invasive haemodynamic measurement protocol utilizing radial pulse wave analysis and whole-body impedance cardiography in both supine position and during head-up tilt. For comparison, haemodynamics of subjects with chronic fatigue syndrome will also be recorded.

Elevated blood pressure (BP) and related cardiovascular complications are the leading causes of morbidity and mortality in the modern world. In routine clinical practice, the haemodynamic status is commonly assessed by measuring heart rate and blood pressure at rest, which provides only limited information about functional haemodynamic status. In addition, the haemodynamic changes resulting in similar elevations of BP may differ substantially between patients and disorders.

Therefore, we investigated the haemodynamic changes in primary and secondary hypertension and in the control subjects with non-invasive radial pulse wave analysis and whole-body impedance cardiography. The method includes the determination of volume status using bioimpedance spectroscopy, determination of peripheral and central BP, cardiac function, vascular resistance, arterial compliance and indices of pulse wave reflection. Besides the measurements performed in the supine position, passive orthostatic challenge is included in the protocol to assess the upright functional haemodynamic status.

The repeatability and reproducibility of the protocol was first examined with a double-blind, randomized protocol in 35 subjects (methodological study group), and after that the administration of research drugs has been open-label. The effects of single doses of two largely endothelium-dependent agents, inhaled salbutamol and intravenous L-arginine, and one endothelium-independent agent, sublingual nitroglycerin, were investigated. However, challenges with the acute dosing of all medical compounds was terminated at the end of December 2016. Thereafter, the measurement protocol has included supine and upright recordings on the tilt-table, followed by supine measurements during paced breathing (15 breaths per minute for 5 minutes, 6 breaths per minute for 5 minutes) that modulate the autonomic nervous tone.

The study population has consisted of subgroups described below. The study protocol of each subgroup has been approved by the ethics committee of the Pirkanmaa Hospital District (Ethics committee ID's above), and the administration of research drugs has also been approved by the Finnish Agency for Medicines (EudraCT-numbers above).

HaemoDYNAMICs in Primary and Secondary Hypertension

Non-Invasive HaemoDYNAMICs in Primary and Secondary Hypertension: the DYNAMIC-study

Haemodynamic measurements are performed at baseline, and after approximately 10 years of follow-up

All cardiovascular events during follow-up

Rapid haemodynamic responses are assessed during the same measurement session (the response to head-up tilt and to research drugs salbutamol, nitroglycerin and L-arginine)

The change in haemodynamic variables after daily consumption of liquorice (2 weeks); bisoprolol (3 weeks); small milk casein-derived polypeptides (12 weeks)

Recordings are performed during normal conditions (training peroid) and after completion of a full-length Ironman competition

Finnish Foundation for Cardiovascular Research

Paavo Nurmi Foundation

Sigrid Jusélius Foundation

Finnish Cultural Foundation

Tampere Tuberculosis Foundation

Medical Research Fund of the Tampere University Hospital, Finland

Aarne Koskelo Foundation

Finnish Medical Foundation

Finnish Kidney Foundation

Päivikki and Sakari Sohlberg Foundation, Finland

Tampere University

MD, PhD, Professor of Internal Medicine

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Breast Neoplasms

Breast Diseases

Skin Diseases

Quality of Life

Phenylalanine

12-weeks, 3-days-a week, supervised aerobic (Nordic walking or Walking) physical exercise (PhE) protocol; duration of each PhE session: 70 minutes; rate of perceived exertion (RPE): 10-11 (1st-4th week); 12-13 (5th-8th week); 13-14 (9th-12th week).

12-weeks, 2.3-days-a week (total of 28 lessons), supervised resistance physical exercise (PhE) protocol; duration of each PhE session: 50 minutes.

Physical exercise

Francesco Bianco, MD, PhD

Valentina Bucciarelli, MD, PhD

To examine the effects of different physical exercise protocols (aerobic training and resistance training) on cardio-vascular efficiency and quality of life in a population of breast cancer survivors (BCS), not treated with chemotherapy.

The present study enrolled a population of BCS women who underwent surgical treatment for breast cancer at the "Ospedale G. Bernabeo" of Ortona, Chieti, Italy. The participants were randomized to the following physical exercise protocols: aerobic training, walking or Nordic walking; resistance training.

All the participants have been examined utilizing transthoracic echocardiography, carotid ultrasound and photo-plethysmographic method for the analysis of arterial stiffness, before and after the physical exercise protocol (T0-T1). The two-dimensional speckle-tracking analysis was performed with an offline, dedicated software from the apical 4-chambers-view. Moreover, ventricular-arterial coupling, epicardial fat thickness and intima-media thickness were also analyzed.

Quality of life was assessed using SF-36 score at T0, T1 and at a mean follow-up of 34 months. Moreover, at follow-up, we evaluated spontaneous physical activity and cardiovascular quality of life using IPAQ and SAQ-7 scores.

Effects of Physical Exercise on Cardio-vascular Efficiency and Quality of Life in Breast Cancer Survivors

The Impact of Different Physical Exercise Protocols on Cardio-vascular Efficiency and Quality of Life in Breast Cancer Survivors

A composite of the improvement in the following parameters, from pre-treatment values: global longitudinal strain analysis, as assessed by speckle-traking echocardiography; ventricular-arterial coupling, as assessed by echocardiographic single beat method; arterial stiffness (pulse wave velocity, augmentation index), as assessed by photoplethysmographic method

A reduction in epicardial fat thickness evaluated with echocardiographic method

A reduction in epicardial fat thickness evaluated with ultrasonographic method

An improvement of quality of life, from pre-treatment values, evaluated with the 36-Item Short Form Health Survey (minimum value: 0, associated with the worst quality of life; maximum value: 100, associated with the best quality of life)

An improvement of spontaneous physical activity evaluated with International Physical Activity Questionnaire score (0-700 MET: low level of physical activity; 700-2519 MET: intermediate level of physical activity; \> 2520 MET: high level of physical activity)

An improvement of quality of life evaluated with the Seattle Angina Questionnaire-7 score (minimum value: 0, associated with more symptoms and with the worst quality of life; maximum value: 100, associated with fewer symptoms and with the best quality of life) where higher scores indicate fewer symptoms and higher health-related quality of life

ITAB - Institute for Advanced Biomedical Technologies

Researcher

Respiratory Tract (Lung and Bronchial) Diseases

Immune System Diseases

Infections

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

Blood and Lymph Conditions

Asthma

Hypersensitivity

Lung Diseases

Fibrosis

Pneumonia

Cystic Fibrosis

Lung Diseases, Interstitial

Lymphangioleiomyomatosis

Respiration Disorders

Respiratory Tract Diseases

Alveolitis, Extrinsic Allergic

Pancreatic Diseases

Gastrointestinal Diseases

Genetic Diseases, Inborn

Infant, Newborn, Diseases

Bronchial Diseases

Lung Diseases, Obstructive

Respiratory Hypersensitivity

Hypersensitivity, Immediate

Communicable Diseases

Respiratory Tract Infections

Lymphangiomyoma

Neoplasms by Histologic Type

Perivascular Epithelioid Cell Neoplasms

Neoplasms, Connective and Soft Tissue

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Chronic Graft Versus Host Disease

Hypersensitivity Pneumonitis

Included patients, aged ≥ 18 years, with chronic respiratory diseases: COPD, bronchial asthma, cystic fibrosis, lymphangioleiomyomatosis, hypersensitivity pneumonitis and other interstitial lung diseases.

Intervention: breath analysis using the Compact PTR-MS proton mass spectrometer by Ionicon (Austria); electrocardiogram (ECG) in one lead with an assessment of the pulse wave using a portable cardiac monitor "CardioQvark"; assessment of arterial stiffness using the VaSera VS-1500N Fukuda Denshi device by non-invasive measurement of blood pressure in four limbs with simultaneous recording of electrocardiogram (ECG), phonocardiogram (PCG) and pulse waves on the carotid, femoral arteries, as well as on the arteries of four limbs.

Interventions:

Diagnostic Test: Breath analysis using the Compact PTR-MS proton mass spectrometer; Diagnostic Test: Portable cardiac monitor "CardioQvark"; Diagnostic Test: Assessment of arterial stiffness using the VaSera VS-1500N.

Included subjects, aged ≥ 18 years.

Intervention: breath analysis using the Compact PTR-MS proton mass spectrometer by Ionicon (Austria); electrocardiogram (ECG) in one lead with an assessment of the pulse wave using a portable cardiac monitor "CardioQvark"; assessment of arterial stiffness using the VaSera VS-1500N Fukuda Denshi device by non-invasive measurement of blood pressure in four limbs with simultaneous recording of ECG, phonocardiogram (PCG) and pulse waves on the carotid, femoral arteries, as well as on the arteries of four limbs.

Interventions:

Diagnostic Test: Breath analysis using the Compact PTR-MS proton mass spectrometer; Diagnostic Test: Portable cardiac monitor "CardioQvark"; Diagnostic Test: Assessment of arterial stiffness using the VaSera VS-1500N.

Breath samples will be analyzed with a proton-transfer reaction mass spectrometer (Compact PTR-MS, Ionicon, Austria) to obtain eVOCs profiles listed as ions at various mass-to-charge ratios (m/z).

Breath test using the Compact PTR-TOF-MS

Record an electrocardiogram (ECG) in one lead with an assessment of the pulse wave using a portable cardiac monitor "CardioQvark" (Russia, LLC "L Card" , RU No. RZN 2019/8124 dated February 15, 2019) once. Devices automatically transfer data to the A\&D Connect app paired with it (link). When transferring data, they are completely protected. The data obtained using the application must be sent to the specialists of the research group in a depersonalized form.

Portable cardiac monitor "CardioQvark"

Assessment of arterial stiffness using the VaSera VS-1500N Fukuda Denshi device by non-invasive measurement of blood pressure in four limbs with simultaneous recording of ECG, PCG and pulse waves on the carotid, femoral arteries, as well as on the arteries of four limbs.

Assessment of arterial stiffness using the VaSera VS-1500N

Assessment of cardiovascular disorders using echocardiography and arterial stiffness; comparative noninvasive assessment of volatile organic compound (eVOC) exhale breath patterns in patients with different chronic respiratory diseases with age and gender-matched healthy adults in order to identify a disease-specific exhaled eVOCs profiles and markers of respiratory and cardiovascular disorders.

Evaluating of eVOCs profiles by proton mass spectrometry with a time-of-flight (PTR-TOF) in patients with different chronic respiratory diseases is of great interest for assessing the prognosis and development of severe ventilation and cardiovascular disorders.

The aim of our study is to determine the diagnostic significance of PTR-TOF analysis in patients with chronic respiratory diseases and to identify specific eVOC markers of a severe ventilation and cardiovascular disorders in patients with different chronic respiratory diseases.

Breath Analysis and Arterial Stiffness in Patients With Respiratory Diseases

Exhaled Breath Proton Mass Spectrometry and Assessment of Endothelial Dysfunction in Patients With Respiratory Diseases

Exhaled volatile organic compounds (eVOCs) profiles listed as ions at various mass-to-charge ratios (m/z)

Pulse wave velocity, augmentation index, pulse wave type (A, B or C) analysed by a portable cardiac monitor "CardioQvark"

Cardio-ankle vascular index and ankle-brachial index analysed with using the VaSera VS-1500N

Clinical data are assessed via questionaire according to the Modified Medical Research Council (mMRC) Dyspnea Scale, Borg Dyspnea scale, standard examination of respiratory function (spirometry, body plethysmography, diffusion test), echocardiography, CT scan of the chest, if necessary, sputum culture results

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
HaemoDYNAMICs in Primary and Secondary Hypertension	NCT01742702	Primary Hyperte... Secondary Hyper... Aortic Stenosis Renal Insuffici...	Nitroglycerin 0... Salbutamol 400 ... L-arginine (10 ... Liquorice (2 we... Small milk case... Bisoprolol (5 m...	18 Years - 99 Years	Tampere University
Effects of Physical Exercise on Cardio-vascular Efficiency and Quality of Life in Breast Cancer Survivors	NCT04337736	Breast Cancer F...	Physical exerci...	- 65 Years	ITAB - Institute for Advanced Biomedical Technologies
Effects of Physical Exercise on Cardio-vascular Efficiency and Quality of Life in Breast Cancer Survivors	NCT04337736	Breast Cancer F...	Physical exerci...	- 65 Years	ITAB - Institute for Advanced Biomedical Technologies
Breath Analysis and Arterial Stiffness in Patients With Respiratory Diseases	NCT05727852	Chronic Respira... Cystic Fibrosis Lymphangioleiom... Hypersensitivit... Interstitial Lu... COPD Bronchial Asthm...	Breath test usi... Portable cardia... Assessment of a...	18 Years -	I.M. Sechenov First Moscow State Medical University

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