Atrial FibrillationPhase 4NCT01435161
Nifedipine vs Telmisartan on Prevention of Atrial Fibrillation (AF) Recurrence in Hypertensive Patients With AF
A Phase 4 study testing Nifedipine, and Telmisartan in people with Atrial Fibrillation, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
Different lowing blood pressure strategies have a different clinical efficacies. Blocking the angiotensin II type 1 receptor (Telmisartan) reduces the incidence of episodes of atrial fibrillation in hypertensive patients with paroxysmal atrial fibrillation during 24 months than 30% compared to Nifedipine( Adalat GITS… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Nifedipine, and Telmisartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- May 2007to Aug 2011
- Phase
- Phase 4
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented hypertensive patients with paroxysmal atrial fibrillation: ECG documentation of atrial fibrillation at least in one ECG recorded during the last 2 months prior to randomization plus additional ECG recording of sinus rhythm at least 12 hours after the above mentioned ECG documentation.
- Patients with hypertensive history were at least 5 years. Systolic pressure > 140mmHg, < 190mmHg, Diastolic pressure > 85mmHg. < 110mmHg.
- 40 < Age < 65 years
Who cannot join
- Strong clinical evidence for therapy with AT II/ACE inhibitors before 3 months of screening
- Therapy with antiarrhythmic agents of class I or class III within the last month, therapy with amiodarone within the last 3 months
- Direct current (DC) cardioversion within the last 3 months
- Symptomatic bradycardia
- Implanted pacemaker or implanted cardioverter/defibrillator with any antitachycardiac algorithm in use
- Cardiac surgery or cardiac catheter ablation within the last 3 months
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- Typical angina pectoris symptoms at rest or during exercise
- Known coronary artery disease with indication for intervention
- Valvular disease > II degree
- Left ventricular ejection fraction < 40%
- Diastolic blood pressure > 110mm Hg at rest
- Symptomatic arterial hypotension
- Known renal artery stenosis
- Serum creatinine > 1.8 mval/l
- Relevant hepatic or pulmonary disorders
- Hyperthyroidism manifested clinically and in laboratory
- Known drug intolerance for AT II inhibitors
- Females who are pregnant or breast feeding
- Females of childbearing potential who are not using a scientifically accepted method of contraception
- Participation in a clinical trial within the last 30 days
- Drug addiction or chronic alcohol abuse
- Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical study
- Evidence of an uncooperative attitude
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nifedipine Versus Telmisartan on Prevention of Atrial Fibrillation Recurrence in Hypertensive Patients With Paroxysmal Atrial Fibrillation by Intensive Lower Blood Pressure
Different lowing blood pressure strategies have a different clinical efficacies. Blocking the angiotensin II type 1 receptor (Telmisartan) reduces the incidence of episodes of atrial fibrillation in hypertensive patients with paroxysmal atrial fibrillation during 24 months than 30% compared to Nifedipine( Adalat GITS ).
A total of 160 subjects will be included in two study groups. The Group 1 will receive 80-160mg Telmisartan per day, the remaining patients will receive Nifedipine ( Adalat GITS). Follow-up is 24 months. The conventional 12-lead ECG recordings at twice weeks interval and 24hrs holter monitor will determine the cardiac rhythm and asymptomatic episodes of atrial fibrillation. The target of Blood pressure after 3 months is less than 130/80mmHg. Concomitant therapy with B-blocker and acethydrazide are allowed for the target blood pressure during the study.
- Conditions
- Atrial Fibrillation
- Being tested
- Nifedipine,, Telmisartan
- Keywords
- paroxysmal atrial fibrillation, hypertension
- Medical subject headings
- Atrial Fibrillation, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine,Drug
Also called anti-hypertensive drugs, Atrial fibrillation
Nifedipine 30-60mg/day
TelmisartanDrug
Also called anti-hypertensive drugs, atrial fibrillation
Telmisartan 80-160mg/day
| Study group | Role | What they receive |
|---|---|---|
| Nifedipine | Active comparator | Patients in arm 1 receive Nifedipine; Receives: Drug: Nifedipine, |
| Telmisartan | Active comparator | Arm 2 receive telmisartan Receives: Drug: Telmisartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of Atrial Fibrillation
Recurrence of Atrial Fibrillation ( at least one readable conventional and Holter ECG recording)
Measured: four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2011 (estimated)
- Study startMay 2007
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
- Investigators
- Yuehui Yin, MD, Study chair, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435161
- Sponsor's protocol ID
- NTP-AF
- Status last verified
- Nov 2012
- First submitted
- 14 Sep 2011
- Last updated
- 16 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nifedipine Versus Telmisartan on Prevention of Atrial Fibrillation Recurrence in Hypertensive Patients With Paroxysmal Atrial Fibrillation by Intensive Lower Blood Pressure
- ClinicalTrials.gov ID
- NCT01435161
- Acronym / sponsor ID
- NTP-AF
- Conditions
- Atrial Fibrillation
- Keywords
- paroxysmal atrial fibrillation, hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 16 Sep 2011 (estimated)
- 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.
Different lowing blood pressure strategies have a different clinical efficacies. Blocking the angiotensin II type 1 receptor (Telmisartan) reduces the incidence of episodes of atrial fibrillation in hypertensive patients with paroxysmal atrial fibrillation during 24 months than 30% compared to Nifedipine( Adalat GITS ).
A total of 160 subjects will be included in two study groups. The Group 1 will receive 80-160mg Telmisartan per day, the remaining patients will receive Nifedipine ( Adalat GITS). Follow-up is 24 months. The conventional 12-lead ECG recordings at twice weeks interval and 24hrs holter monitor will determine the cardiac rhythm and asymptomatic episodes of atrial fibrillation. The target of Blood pressure after 3 months is less than 130/80mmHg. Concomitant therapy with B-blocker and acethydrazide are allowed for the target blood pressure during the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nifedipine | Active comparator | Drug: Nifedipine,Patients in arm 1 receive Nifedipine; |
| Telmisartan | Active comparator | Drug: TelmisartanArm 2 receive telmisartan |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documented hypertensive patients with paroxysmal atrial fibrillation: ECG documentation of atrial fibrillation at least in one ECG recorded during the last 2 months prior to randomization plus additional ECG recording of sinus rhythm at least 12 hours after the above mentioned ECG documentation.
- Patients with hypertensive history were at least 5 years. Systolic pressure > 140mmHg, < 190mmHg, Diastolic pressure > 85mmHg. < 110mmHg.
- 40 < Age < 65 years
Key exclusion criteria (23 listed)
- Strong clinical evidence for therapy with AT II/ACE inhibitors before 3 months of screening
- Therapy with antiarrhythmic agents of class I or class III within the last month, therapy with amiodarone within the last 3 months
- Direct current (DC) cardioversion within the last 3 months
- Symptomatic bradycardia
- Implanted pacemaker or implanted cardioverter/defibrillator with any antitachycardiac algorithm in 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 |
|---|---|---|
| Nifedipine,Also: anti-hypertensive drugs, Atrial fibrillationNifedipine 30-60mg/day | Drug | Nifedipine |
| TelmisartanAlso: anti-hypertensive drugs, atrial fibrillationTelmisartan 80-160mg/day | Drug | Telmisartan |
Primary outcome
Recurrence of Atrial Fibrillation
Time frame: four years
Recurrence of Atrial Fibrillation ( at least one readable conventional and Holter ECG recording)
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 16 Nov 2012.
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Atrial Fibrillation (AF)
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.
Yuehui Yin, MD study chair
The Second Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nifedipine, and Telmisartan in people with Atrial Fibrillation, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
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 3 inclusion and 23 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 16 Nov 2012. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Recurrence of Atrial Fibrillation (time frame: four years). 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 16 Nov 2012.