Completed

Exercise Training and Non-Invasive Ventilation for Acute Heart Failure Patients

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Study Aim

This study aims to evaluate the safety and effectiveness of exercise training combined with non-invasive ventilation in patients with acute heart failure, observing outcomes such as hospital discharge, worsening of heart failure, or death.

What is being tested

Exercise

Other
Who is being recruted

Behavior+2

+ Cardiovascular Diseases

+ Heart Diseases

Over 18 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: July 2010
See protocol details

Summary

Principal SponsorInstituto Dante Pazzanese de Cardiologia
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2010

Actual date on which the first participant was enrolled.

This study focuses on understanding the safety and effectiveness of exercise training in patients who have been hospitalized due to acute heart failure. Acute heart failure is a condition where the heart suddenly can't pump blood efficiently, causing symptoms like shortness of breath and fatigue. The study aims to find out if exercise training, along with standard medical treatment, can help improve these symptoms and overall health outcomes. The study involves patients who are currently in the hospital for acute heart failure. Upon admission, patients undergo an individualized clinical evaluation by a cardiologist and a physiotherapist. This includes tests like pulmonary function tests, blood samples, a six-minute walk test, and a maximal inspiratory pressure test. Patients are then divided into three groups. One group receives only standard medical treatment, while the other two groups receive medical treatment and exercise training. One of these two groups also receives non-invasive ventilation (NIV) during exercise, while the other receives a placebo NIV. After eight days, all patients undergo a new clinical evaluation. Following this, they continue to receive only standard medical treatment and are monitored for outcomes such as hospital discharge, worsening heart failure, or death.

Official TitleSafety and Efficacy of Exercise Training in Patients With Acute Heart Failure: a Pilot Study
Principal SponsorInstituto Dante Pazzanese de Cardiologia
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

29 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorCardiovascular DiseasesHeart DiseasesHeart FailureMotor Activity

Criteria

1 inclusion criteria required to participate
established diagnosis of acute HF; previous Doppler echocardiography with left ventricle ejection fraction (LVEF) <30%, and NYHA Class IV.

1 exclusion criteria prevent from participating
unstable angina, complex cardiac arrhythmias, pacemaker, cardiac resynchronization therapy or left ventricle assist device, myocardial infarction within the previous 12 months, oxygen saturation by pulse oximetry (SpO2) at rest < 88% without oxygen supplementation, acute pulmonary edema with clinical indications for mechanical ventilation

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Patients who receiveid only conventional medical treatment and not performed exercise during protocol.

Group II

Sham
Patients with acute haert failure who performed aerobic exercise with placebo of non-invasive ventilation. This group also received conventional medical treatment.

Group III

Experimental
Patients with acute haert failure who performed aerobic exercise with non-invasive ventilation. This group also received conventional medical treatment.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers