Cardiovascular Response to Exercise in Hypertension

NCT02634866 | Completed

• 1 other identifier: 0000000336
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Arterial hypertension (AH) is an important clinical social and economic problem, related to the increased cardiovascular risk. AH is associated with cardiovascular hemodynamic alterations, including left ventricular diastolic dysfunction (LVddf). In consequence of increased blood pressure, the effectiveness of LV as a blood pump decreases and the symptoms of heart failure (HF) may occur. Thus, the identification of noninvasive markers related with the progression from the asymptomatic AH to LVddf/HFpEF would be beneficial. Another issue is that the diagnostic difficulties in patients with LVddf and HFpEF stem from the limited possibility to assess the hemodynamic response to exercise. Thus, there is a need for more detailed methods of cardiovascular monitoring while exercise testing. We hypothesize that some new noninvasive hemodynamic parameters, characterizing left ventricular (LV) function and arterial stiffness, may help to predict the risk of cardiovascular events and future occurrence of LVddf/HFpEF. Moreover, we assume that cardiopulmonary exercise test (CPET), completed with new methods of noninvasive hemodynamic monitoring (impedance cardiography and applanation tonometry), would provide additional value in the assessment of the cardiovascular hemodynamic response to exercise. The study is intended to verify these hypothesis.

Conditions

Hypertension

Keywords

hypertension; exercise; diastolic heart failure

Outcome Measures

Primary Outcomes (1)

• complex end-point (death from cardiovascular causes and/or myocardial infarction and/or stroke and/or decompensated heart failure)

  Any of the following cardiovascular events: death from cardiovascular causes and/or myocardial infarction and/or stroke and/or decompensated heart failure

  48 months

Secondary Outcomes (5)

• death from any cause

  48 months

• death from cardiovascular causes

  48 months

• myocardial infarction

  48 months

• decompensated heart failure

  48 months

• stroke

  48 months

Other Outcomes (4)

• new-onset of heart failure after 12 months (in groups N i D)

  12 months

• new-onset of heart failure after 24 months (in groups N i D)

  24 months

• new-onset of left ventricular diastolic dysfunction in echocardiography after 12 months (in group N)

  12 months

Study Arms (3)

Group N

The subjects with no symptoms of HF and normal left ventricular diastolic function (no less than 40 subjects)

Group D

The subjects with no symptoms of HF and left ventricular diastolic dysfunction (no less than 40 subjects)

Group D_HF

The subjects with symptoms of HF and left ventricular diastolic dysfunction (no less than 40 subjects)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

No less than 120 hypertensive subjects (both sexes, aged 40-75 years) will be enrolled, including those with: 1/ no symptoms of HF and normal LV diastolic function (group N, no less than 40 subjects), 2/ no symptoms of HF and LVddf (group D, no less than 40 subjects), 3/ with symptoms of both HF and LVddf (group D\_HF, no less than 40 subjects).

You may qualify if:

• patients of either sex
• age 40-75 years
• arterial hypertension diagnosed ≥3 months before recruitment.

You may not qualify if:

• office blood pressure \> 160/100 mmHg
• coronary artery disease
• systolic heart failure (LVEF below 45%) and/or severe heart defect (i.e. valvular disease)
• severe pulmonary diseases (COPD stage C/D, uncontrolled asthma, pulmonary hypertension, pulmonary embolism)
• chronic kidney disease (MDRD eGFR\<60 ml/min/1.73m2)
• severe inflammatory disease
• severe mental and physical disorders
• polyneuropathy
• obesity with BMI \> 40 kg/m2
• life expectancy less than 12 months in the opinion of the physician
• patients' refusal to participate.

Sponsors & Collaborators

• Military Institute od Medicine National Research Institute: lead

Study Sites (1)

Military Institute of Medicine

Warsaw, Masovian Voivodeship, 04-141, Poland

Location

MeSH Terms

Conditions

Hypertension; Motor Activity; Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior; Heart Failure; Heart Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 18, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 26, 2021

Record last verified: 2021-02

Locations

PL (1)