Chronic Heart FailureNCT03710057
Effect of Ivabradine in Lowering Heart Rate and Quality of Life in Chronic Heart Failure Patients
An observational study of Chronic Heart Failure, run by Getz Pharma.
Trial summary
Elevated Heart rate (HR) (≥ 70 bpm) is one of the contributing factors in increasing the burden of hospitalization among Heart Failure patient. Ivabradine is a novel, selective and specific in inhibiting a Funny current in sinoatrial node Node and approved as an alternative therapy for Chronic Heart Failure (CHF)… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Ivabradine
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 15 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population was included male or female patients with Chronic Heart Failure (CHF). Diagnosis of CHF as per Boston Criteria for Diagnosing Heart failure and the New York Heart Association (NYHA) functional class II to III classification and rest on the based on the medical judgment of the investigator after review of subject's medical history, results of routine screening physical and general examination and routine laboratory investigations. Patients' written authorization was used to obtain patients' data. However, patient data secrecy was followed by ICH GCP requirements.
Who may be able to join
- Written informed consent
- Known case of Chronic Heart Failure (New York Heart Association (NYHA) functional class II to III)
- Clinically stability (at least for 4 weeks)
- Resting heart rate of more than 70 beats/ min (bpm) as assessed from the 12-lead electrocardiogram.
Who cannot join
- Hypersensitivity to the active substance or to any of the excipients
- Resting heart rate below 70 beats per minute prior to treatment
- Cardiogenic shock
- Acute myocardial infarction
- Severe hypotension (< 90/50 mmHg)
- Severe hepatic insufficiency
Show all 15Show fewer
- Sick sinus syndrome
- Sino-atrial block
- Unstable or acute heart failure
- Pacemaker dependent (heart rate imposed exclusively by the pacemaker)
- Unstable angina
- Atrioventricular Block of 3rd degree
- The combination with a strong cytochrome P450 3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone
- The combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties.
- Pregnancy, lactation and women of child-bearing potential not using appropriate contraceptive measures
About this study
Official title: A Post-Marketing, Prospective, Observational Program: Effect of Ivabradrine in Lowering Heart Rate and Quality of Life in Chronic Heart Failure Patients
Elevated Heart rate (HR) (≥ 70 bpm) is one of the contributing factors in increasing the burden of hospitalization among Heart Failure patient. Ivabradine is a novel, selective and specific in inhibiting a Funny current in sinoatrial node Node and approved as an alternative therapy for Chronic Heart Failure (CHF) patients. CHF patients when treated with Ivabradine reported 39%, and 30% reduction in mortality and hospitalization rate respectively. Patient were treated with Ivabradine 5mg twice daily to determine its effect in lowering Heart rate and the Quality of Life (QOL) in Chronic Heart Failure patients
Read the detailed description
A prospective, post-marketing observational study was conducted in 50 chronic heart failure patients with age 30-70yrs of NYHA Class II and prescribed 5 mg Ivabradine twice daily. Heart rate was evaluated through ECG \& quality of life was measured by a validated questionnaire EuroQol-5 Dimension 3 level version (EQ-5D-3L). Baseline demographic includes age, gender, height, weight, Body Mass Index, temperature, blood pressure and respiratory rate were recorded and patients were followed at week 4 and week 8. Safety and tolerability was assessed by adverse drug reaction (ADR) monitoring. Results were analyzed by statistical software SPSS version 20.0.
- Conditions
- Chronic Heart Failure
- Being tested
- Ivabradine
- Keywords
- Ivabradine, Heart Rate, Health Related Quality of Life, Safety, Chronic Heart Failure Patient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvabradineDrug
A prospective, post-marketing observational study was conducted in National Institute of cardiovascular disease, Karachi-Pakistan. Total 50 patients were advised to take 5 mg Ivabradine (SIVAB) twice daily for 8 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference of Heart Rate
The primary end-point was the overall response rate of patients to Ivabradine in achieving HR <70 Bpm
Measured: at 4 week and 8 week
Secondary outcomes (2)
Percentage of problems reported in EQ-5D descriptive system
Quality of Life was determined through validated questionnaire EQ-5D-3L. It also assesses five dimensions of HR quality of life (HRQoL): mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension is measured one to three levels i.e 1, 2, 3. Where level 2 \& 3 indicates 'problem' and level 1 denotes to 'no problem'.
Measured: at 4 week and 8 week
Median score of EQ-5D visual analogue scale
The EQ-5D registers the self-rated health status of the respondent on the vertically visual analogue scale (EQ-5D VAS) from 0 to 100 where 100 indicates 'Best imaginable health' and 0 is said to be a 'Worst imagine health state'.
Measured: at 4 week and 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start1 Dec 2016
- Primary completion14 Feb 2017
- Study completion15 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Getz Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr. Fawad Farooq, National Institute of Cardiovascular Diseases, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710057
- Sponsor's protocol ID
- GTZ-CVD-001
- Status last verified
- Oct 2018
- First submitted
- 11 Oct 2018
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Marketing, Prospective, Observational Program: Effect of Ivabradrine in Lowering Heart Rate and Quality of Life in Chronic Heart Failure Patients
- ClinicalTrials.gov ID
- NCT03710057
- Acronym / sponsor ID
- GTZ-CVD-001
- Conditions
- Chronic Heart Failure
- Keywords
- Ivabradine, Heart Rate, Health Related Quality of Life, Safety, Chronic Heart Failure Patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Getz PharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 14 Feb 2017 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Elevated Heart rate (HR) (≥ 70 bpm) is one of the contributing factors in increasing the burden of hospitalization among Heart Failure patient. Ivabradine is a novel, selective and specific in inhibiting a Funny current in sinoatrial node Node and approved as an alternative therapy for Chronic Heart Failure (CHF) patients. CHF patients when treated with Ivabradine reported 39%, and 30% reduction in mortality and hospitalization rate respectively. Patient were treated with Ivabradine 5mg twice daily to determine its effect in lowering Heart rate and the Quality of Life (QOL) in Chronic Heart Failure patients
Detailed description
A prospective, post-marketing observational study was conducted in 50 chronic heart failure patients with age 30-70yrs of NYHA Class II and prescribed 5 mg Ivabradine twice daily. Heart rate was evaluated through ECG \& quality of life was measured by a validated questionnaire EuroQol-5 Dimension 3 level version (EQ-5D-3L). Baseline demographic includes age, gender, height, weight, Body Mass Index, temperature, blood pressure and respiratory rate were recorded and patients were followed at week 4 and week 8. Safety and tolerability was assessed by adverse drug reaction (ADR) monitoring. Results were analyzed by statistical software SPSS version 20.0.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population was included male or female patients with Chronic Heart Failure (CHF). Diagnosis of CHF as per Boston Criteria for Diagnosing Heart failure and the New York Heart Association (NYHA) functional class II to III classification and rest on the based on the medical judgment of the investigator after review of subject's medical history, results of routine screening physical and general examination and routine laboratory investigations. Patients' written authorization was used to obtain patients' data. However, patient data secrecy was followed by ICH GCP requirements.
Key inclusion criteria (4 listed)
- Written informed consent
- Known case of Chronic Heart Failure (New York Heart Association (NYHA) functional class II to III)
- Clinically stability (at least for 4 weeks)
- Resting heart rate of more than 70 beats/ min (bpm) as assessed from the 12-lead electrocardiogram.
Key exclusion criteria (15 listed)
- Hypersensitivity to the active substance or to any of the excipients
- Resting heart rate below 70 beats per minute prior to treatment
- Cardiogenic shock
- Acute myocardial infarction
- Severe hypotension (< 90/50 mmHg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IvabradineA prospective, post-marketing observational study was conducted in National Institute of cardiovascular disease, Karachi-Pakistan. Total 50 patients were advised to take 5 mg Ivabradine (SIVAB) twice daily for 8 weeks. | Drug | – |
Primary outcome
Mean difference of Heart Rate
Time frame: at 4 week and 8 week
The primary end-point was the overall response rate of patients to Ivabradine in achieving HR <70 Bpm
2 secondary outcomes
Percentage of problems reported in EQ-5D descriptive system
Time frame: at 4 week and 8 week
Median score of EQ-5D visual analogue scale
Time frame: at 4 week and 8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure, run by Getz Pharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference of Heart Rate (time frame: at 4 week and 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.