Completed

DIGvsIVADigoxin vs. Ivabradine in Heart Failure with Preserved Systolic Function

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Study Aim

This observational study aims to compare the effects of Digoxin and Ivabradine on heart function, specifically focusing on both diastolic and systolic functions, in individuals with heart failure who have preserved systolic function.

What is being collected

Drug Data

Collected from today forward - Prospective
Drug
Who is being recruted

Arrhythmias, Cardiac+4

+ Cardiovascular Diseases

+ Heart Diseases

From 60 to 78 Years
See all eligibility criteria
How is the trial designed

Case-Crossover

Comparing exposures during disease occurrence and non-occurrence in order to assess the short-term effects of triggers.
Observational
Study Start: April 2008
See protocol details

Summary

Principal SponsorCocco, Giuseppe, M.D.
Last updated: February 1, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2008

Actual date on which the first participant was enrolled.

Selected patients had chronic coronary artery disease which had been treated with percutaneous dilatation & stenting and/or aortocoronary bypass. The severity of myocardial ischemia had induced heart failure with diastolic dysfunction and preserved systolic function, and permanent AF. 1 Inclusion criteria: Dyspnea class III NYHA. Abnormal left ventricular relaxation with preserved (≥52%) ejection fraction (LVEF). Patients either in sinus rhythm or with permanent atrial fibrillation. 2. Exclusion criteria: Unstable angina pectoris. Reduced systolic cardiac function (LVEF<52%). Normal diastolic function. Diabetes requiring insulin. Moderate or severe renal or hepatic dysfunction. Technically insufficient echocardiography.

NCT01796093
Principal SponsorCocco, Giuseppe, M.D.
Last updated: February 1, 2017
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

42 patients to be enrolled

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

Case-Crossover

In this design, participants serve as their own control. Researchers compare a person's exposures just before a health event with exposures at other times, helping identify short-term triggers or risk factors.

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.

From 60 to 78 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

Arrhythmias, CardiacCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsAtrial FibrillationHeart Failure

Criteria

Inclusion Criteria: No need to change concomitant pharmacological therapy in the following months, dyspnea class III NYHA, and abnormal left ventricular relaxation with preserved (≥52%) left ventricular ejection fraction (LVEF). Exclusion Criteria: Unstable myocardial ischemia, reduced systolic cardiac function (LVEF<52%), diabetes mellitus requiring insulin, moderate or severe renal or hepatic dysfunction, or technically insufficient echocardiography.

Study Plan

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

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary 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 1 location

Cardiology office

Rheinfelden, SwitzerlandOpen Cardiology office in Google Maps
CompletedOne Study Center