Heart FailureNCT03830957
Efficacy and Safety of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker
A study testing Ivabradine and Metoprolol in people with Heart Failure and CT Angiography, run by Rajaie Cardiovascular Medical and Research Center at 1 site in Iran.
Trial summary
The aim of this study is to compare the effects of Ivabradine and metoprolol to reduce heart rate prior to coronary CT angiography in patients with advanced heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, CT Angiography, Ischemic Cardiomyopathy
- What is being tested?
- Ivabradine and Metoprolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIran
- Study dates
- 26 Nov 2018to Dec 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sinus rhythm
- Heart rate >60/min
Who cannot join
- Atrial fibrillation
- Any contraindication for beta-blocker use
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Ahmad Amin
Tehran, 1996911151
Ahmad Amin, MD, +98 21 2392 ext. 2172, amina33@gmail.com
About this study
Official title: Randomized Clinical Trial of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker
The aim of this study is to compare the effects of Ivabradine and metoprolol to reduce heart rate prior to coronary CT angiography in patients with advanced heart failure.
- Conditions
- Heart Failure, CT Angiography, Ischemic Cardiomyopathy, Non-ischemic Cardiomyopathy, Heart Failure, Systolic, Heart Failure，Congestive
- Being tested
- Ivabradine, Metoprolol
- Medical subject headings
- Heart Failure, Heart Failure, Systolic, Heart Failure, Diastolic, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvabradineDrug
7.5 mg oral single dose if the heart rate would not reach to 60/minute then give another dose, 7.5 mg
MetoprololDrug
5 mg oral single dose if the heart rate would not reach to 60/minute then give another dose, 5 mg
| Study group | Role | What they receive |
|---|---|---|
| Ivabradine | Active comparator | Not described Receives: Drug: Ivabradine |
| metoprolol | Active comparator | Not described Receives: Drug: Metoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Changing heart rate during imaging study
Measured: 30 minutes before and after coronary CT angiography
Secondary outcomes (7)
Dyspnea
Shortness of breath, or "dyspnea", is the most famous symptom of left ventricular failure. It typically appears during strenuous activities, and progresses to ordinary activities, less than ordinary activities and ultimately resting state. The severity is categorized as above (FC 1 to 4)
Measured: 30 minutes before and after coronary CT angiography and 6 months later
Functional calss
Heart Failure severity has been classified according to New York Heart Association (NYHA) to:
- Class I: No limitation of physical activity. Ordinary physical activity does not cause symptoms of HF.
- Class II: Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in symptoms of HF.
- Class III: Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes symptoms of HF.
- Class IV: Unable to perform any physical activity without symptoms of HF, or symptoms of HF at rest.
Measured: 30 minutes before and after coronary CT angiography and 6 months later
Blood pressure, systolic and diastolic
The amount of blood pressure measured by sphygmomanometer
Measured: 30 minutes before and after coronary CT angiography and 6 months later
Sleep quality
The rate of disturbed sleep measured as better than before, Worse than before, and No change
There are no standard classification for severity of this symptom. In our study, we measure this symptom as :
- Better than before (1)
- Worse than before (2)
- No change (0)
Measured: Before CT angiography and 6 months later
Appetite
The rate of changing in appetite level measured as better than before, Worse than before, and No change
Loss of appetite is a common symptom of heart failure. There are no standard classification for severity of this symptom. In our study, we measure this symptom as :
- Better than before (1)
- Worse than before (2)
- No change (0)
Measured: Before CT angiography and 6 months later
Prolonged bradycardia
Persistence of Bradycardia more than 6 hours is called prolonged bradycardia.
Measured: 30 minutes before and after coronary CT angiography
Hypotension
Systolic less than 80 mm Hg
Measured: 30 minutes before and after coronary CT angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start26 Nov 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rajaie Cardiovascular Medical and Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830957
- Sponsor's protocol ID
- HFRC_01
- Status last verified
- Apr 2019
- First submitted
- 26 Nov 2018
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker
- ClinicalTrials.gov ID
- NCT03830957
- Acronym / sponsor ID
- HFRC_01
- Conditions
- Heart Failure, CT Angiography, Ischemic Cardiomyopathy, Non-ischemic Cardiomyopathy, Heart Failure, Systolic, Heart Failure，Congestive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rajaie Cardiovascular Medical and Research CenterUniversity, hospital or other
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 5 Feb 2019 (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.
The aim of this study is to compare the effects of Ivabradine and metoprolol to reduce heart rate prior to coronary CT angiography in patients with advanced heart failure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivabradine | Active comparator | Drug: Ivabradine |
| metoprolol | Active comparator | Drug: Metoprolol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sinus rhythm
- Heart rate >60/min
Key exclusion criteria (2 listed)
- Atrial fibrillation
- Any contraindication for beta-blocker use
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 |
|---|---|---|
| Ivabradine7.5 mg oral single dose if the heart rate would not reach to 60/minute then give another dose, 7.5 mg | Drug | Ivabradine |
| Metoprolol5 mg oral single dose if the heart rate would not reach to 60/minute then give another dose, 5 mg | Drug | metoprolol |
Primary outcome
Heart rate
Time frame: 30 minutes before and after coronary CT angiography
Changing heart rate during imaging study
7 secondary outcomes
Dyspnea
Time frame: 30 minutes before and after coronary CT angiography and 6 months later
Functional calss
Time frame: 30 minutes before and after coronary CT angiography and 6 months later
Blood pressure, systolic and diastolic
Time frame: 30 minutes before and after coronary CT angiography and 6 months later
Sleep quality
Time frame: Before CT angiography and 6 months later
Appetite
Time frame: Before CT angiography and 6 months later
Prolonged bradycardia
Time frame: 30 minutes before and after coronary CT angiography
Hypotension
Time frame: 30 minutes before and after coronary CT angiography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ivabradine and Metoprolol in people with Heart Failure and CT Angiography, run by Rajaie Cardiovascular Medical and Research Center at 1 site in Iran.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: 30 minutes before and after coronary CT angiography). 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 12 Apr 2019.