ProlactinomasValveCabNCT00460616
Cardiac Valve Complications in Prolactinomas Treated With Cabergoline
An observational study of Prolactinomas, run by Federico II University at 1 site in Italy.
Trial summary
Dopamine agonists are first-line agents for the treatment of prolactinomas (1) and Parkinson's disease (2). There is evidence supporting a causal relationship between the occurrence of drug-induced "restrictive" valvular heart disease and treatment with pergolide (3): in several cases, the valvulopathy improved when… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prolactinomas
- What is being tested?
- Cabergoline
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2007to Sep 2007
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Three different study populations will be studied. * Group 1) Patients already receiving treatment with cabergoline for at least 12 months * Group 2) Newly diagnosed patients with hyperprolactinemia who never received treatment with dopamine-agonists * Group 3) Non hyperprolactinemic subjects matched with the patients for sex and age to be used as controls.
Who may be able to join
- Patients with documented hyperprolactinemia receiving continuous treatment with cabergoline only for at least 12 months
- Newly diagnosed patients with prolactinoma never previously receiving dopamine agonists treatment
Who cannot join
- A history of cardiac valve abnormalities,
- Previous use of anorectic drugs or other ergot-derived drugs,
- Treatment with cabergoline for less than 12 months,
- Valve calcification, valve regurgitation associated with annular dilatation or excessive leaflet motion,
- Mitral regurgitation associated with left ventricular wall-motion abnormalities or left ventricular dilatation,
- Withdrawal from cabergoline treatment for longer than 1 month, according with our treatment protocol (11).
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Molecular and Clinical Endocrinology and Oncology, University Federico II of Naples
Via S. Pansini 5 Naples, 80131
About this study
Official title: Observational Study to Investigate the Prevalence of Cardiac Abnormalities and Valvular Regurgitation in Patients With Prolactinomas Treated Chronically With Cabergoline
Dopamine agonists are first-line agents for the treatment of prolactinomas (1) and Parkinson's disease (2). There is evidence supporting a causal relationship between the occurrence of drug-induced "restrictive" valvular heart disease and treatment with pergolide (3): in several cases, the valvulopathy improved when pergolide was discontinued (4). Valvular heart damage has also been reported with the ergot-derived dopamine agonists bromocriptine and cabergoline (5,6).
Two recent studies (7,8) have further demonstrated that both pergolide and cabergoline are associated with an increased risk of new cardiac valve regurgitation in patients treated for Parkinson's disease.
Read more
The valvular abnormalities seen with ergot-derived dopamine agonists are similar to those observed in patients receiving ergot alkaloid agents (such as ergotamine and methysergide) in the treatment of migraine, or fenfluramine and dexfenfluramine in the treatment of obesity. These abnormalities also closely resemble carcinoid-related valvulopathies (9).
Cardiac valve disease has never been reported in patients with prolactinomas who require treatment with dopamine-agonists even life-long (1). At variance with patients with Parkinson's disease, patients with prolactinomas are younger and are treated with an average dose of dopamine-agonists that is significantly lower (median bromocriptine dose 5 mg/day and median cabergoline dose 1 mg/week). Because of the young age of treatment beginning (most patients with microprolactinomas start dopamine-agonist treatment in early adulthood), treatment might be continued for over 3 decades: the cumulative risk of low doses of dopamine agonists for such a long period of treatment is currently unknown.
To assess the prevalence of cardiac valve disease in patients treated with cabergoline, we wish to perform an echocardiography screening in a large representative sample of patients with prolactinoma who were treated with cabergoline for at least 12 months and in a group of control subjects recruited prospectively. We wish to evaluate the severity of regurgitation for the mitral, aortic, and tricuspid valves. Changes in cardiac valve apparatus was compared with treatment duration and cumulative cabergoline dose.
Read the detailed description
Within one week from a clinical observation in the outpatient service, all patients will be admitted to the hospital for a complete endocrine screening, a cardiological visit that will include an electrocardiogram and an echocardiogram.
The endocrine profile will include measurement of IGF-I, PRL, FSH, LH, 17-β-estradiol, testosterone, FT3, FT4, TSH, and cortisol at 8.00 in the morning after an overnight fasting.
The clinical profile will include blood pressure measurement at the right arm, with the subjects in relaxed sitting position. The average of six measurements (three taken by each of two examiners, in the same day of echocardiography, between 8.00-9.00 in the morning) with a mercury sphygmomanometer will be used in all analysis. According with the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (10), hypertension, if present, is classified as mild (Stage 1) when the SBP or DBP were between 140 and 159 mmHg and between 90 and 99 mmHg, respectively; severe (Stage 2) when the SBP or DBP were >160 and >100 mmHg respectively; pre-hypertension is defined as SBP >120¬ and <140 and DBP >80 and <90 mmHg. Heart rate will be also measured.
- Conditions
- Prolactinomas
- Being tested
- Cabergoline
- Keywords
- Prolactin, Prolactinomas, Dopamine-Agonists, Cabergoline, Cardiac valve disease
- Medical subject headings
- Prolactinoma, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabergolineDrug
Also called Dostinex
According with our previous studies, in the patients with microprolactinoma and in those with non-tumoral hyperprolactinemia, cabergoline treatment was administered orally at a starting dose of 0.25 mg twice weekly for the first two weeks and then 0.5 mg twice weekly. After 2 months of treatment, dose adjustment was carried out every 2 months on the basis of serum PRL suppression.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients already receiving treatment with cabergoline. Receives: Drug: Cabergoline | |
| 2 | healthy controls sex and age-matched with the patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of regurgitation (graded as mild, moderate, severe) at any cardiac valve.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2007 (estimated)
- Study startJan 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for ProlactinomasStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Investigators
- Annamaria AL Colao, Prof., Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460616
- Sponsor's protocol ID
- NeuroendoUnit-2
- Acronym
- ValveCab
- Status last verified
- Oct 2007
- First submitted
- 13 Apr 2007
- Last updated
- 16 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.
PubMed 12748199Gillam MP, Molitch ME, Lombardi G, Colao A. Advances in the treatment of prolactinomas. Endocr Rev. 2006 Aug;27(5):485-534. doi: 10.1210/er.2005-9998. Epub 2006 May 26.
PubMed 16705142Nutt JG, Wooten GF. Clinical practice. Diagnosis and initial management of Parkinson's disease. N Engl J Med. 2005 Sep 8;353(10):1021-7. doi: 10.1056/NEJMcp043908. No abstract available.
PubMed 16148287Flowers CM, Racoosin JA, Lu SL, Beitz JG. The US Food and Drug Administration's registry of patients with pergolide-associated valvular heart disease. Mayo Clin Proc. 2003 Jun;78(6):730-1. doi: 10.4065/78.6.730. No abstract available.
PubMed 12934784Van Camp G, Flamez A, Cosyns B, Weytjens C, Muyldermans L, Van Zandijcke M, De Sutter J, Santens P, Decoodt P, Moerman C, Schoors D. Treatment of Parkinson's disease with pergolide and relation to restrictive valvular heart disease. Lancet. 2004 Apr 10;363(9416):1179-83. doi: 10.1016/S0140-6736(04)15945-X.
PubMed 15081648Pinero A, Marcos-Alberca P, Fortes J. Cabergoline-related severe restrictive mitral regurgitation. N Engl J Med. 2005 Nov 3;353(18):1976-7. doi: 10.1056/NEJM200511033531822. No abstract available.
PubMed 16267335Serratrice J, Disdier P, Habib G, Viallet F, Weiller PJ. Fibrotic valvular heart disease subsequent to bromocriptine treatment. Cardiol Rev. 2002 Nov-Dec;10(6):334-6. doi: 10.1097/00045415-200211000-00005.
PubMed 12390688Schade R, Andersohn F, Suissa S, Haverkamp W, Garbe E. Dopamine agonists and the risk of cardiac-valve regurgitation. N Engl J Med. 2007 Jan 4;356(1):29-38. doi: 10.1056/NEJMoa062222.
PubMed 17202453Zanettini R, Antonini A, Gatto G, Gentile R, Tesei S, Pezzoli G. Valvular heart disease and the use of dopamine agonists for Parkinson's disease. N Engl J Med. 2007 Jan 4;356(1):39-46. doi: 10.1056/NEJMoa054830.
PubMed 17202454Botero M, Fuchs R, Paulus DA, Lind DS. Carcinoid heart disease: a case report and literature review. J Clin Anesth. 2002 Feb;14(1):57-63. doi: 10.1016/s0952-8180(01)00353-1.
PubMed 11880025Colao A, Di Sarno A, Cappabianca P, Di Somma C, Pivonello R, Lombardi G. Withdrawal of long-term cabergoline therapy for tumoral and nontumoral hyperprolactinemia. N Engl J Med. 2003 Nov 20;349(21):2023-33. doi: 10.1056/NEJMoa022657.
PubMed 14627787Auriemma RS, Pivonello R, Perone Y, Grasso LF, Ferreri L, Simeoli C, Iacuaniello D, Gasperi M, Colao A. Safety of long-term treatment with cabergoline on cardiac valve disease in patients with prolactinomas. Eur J Endocrinol. 2013 Aug 28;169(3):359-66. doi: 10.1530/EJE-13-0231. Print 2013 Sep.
PubMed 23824978Colao A, Galderisi M, Di Sarno A, Pardo M, Gaccione M, D'Andrea M, Guerra E, Pivonello R, Lerro G, Lombardi G. Increased prevalence of tricuspid regurgitation in patients with prolactinomas chronically treated with cabergoline. J Clin Endocrinol Metab. 2008 Oct;93(10):3777-84. doi: 10.1210/jc.2007-1403. Epub 2008 Aug 5.
PubMed 18682513
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Investigate the Prevalence of Cardiac Abnormalities and Valvular Regurgitation in Patients With Prolactinomas Treated Chronically With Cabergoline
- ClinicalTrials.gov ID
- NCT00460616
- Acronym / sponsor ID
- ValveCab / NeuroendoUnit-2
- Conditions
- Prolactinomas
- Keywords
- Prolactin, Prolactinomas, Dopamine-Agonists, Cabergoline, Cardiac valve disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Sep 2007 (actual)
- First posted
- 16 Apr 2007 (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.
Dopamine agonists are first-line agents for the treatment of prolactinomas (1) and Parkinson's disease (2). There is evidence supporting a causal relationship between the occurrence of drug-induced "restrictive" valvular heart disease and treatment with pergolide (3): in several cases, the valvulopathy improved when pergolide was discontinued (4). Valvular heart damage has also been reported with the ergot-derived dopamine agonists bromocriptine and cabergoline (5,6).
Two recent studies (7,8) have further demonstrated that both pergolide and cabergoline are associated with an increased risk of new cardiac valve regurgitation in patients treated for Parkinson's disease.
The valvular abnormalities seen with ergot-derived dopamine agonists are similar to those observed in patients receiving ergot alkaloid agents (such as ergotamine and methysergide) in the treatment of migraine, or fenfluramine and dexfenfluramine in the treatment of obesity. These abnormalities also closely resemble carcinoid-related valvulopathies (9).
Cardiac valve disease has never been reported in patients with prolactinomas who require treatment with dopamine-agonists even life-long (1). At variance with patients with Parkinson's disease, patients with prolactinomas are younger and are treated with an average dose of dopamine-agonists that is significantly lower (median bromocriptine dose 5 mg/day and median cabergoline dose 1 mg/week). Because of the young age of treatment beginning (most patients with microprolactinomas start dopamine-agonist treatment in early adulthood), treatment might be continued for over 3 decades: the cumulative risk of low doses of dopamine agonists for such a long period of treatment is currently unknown.
To assess the prevalence of cardiac valve disease in patients treated with cabergoline, we wish to perform an echocardiography screening in a large representative sample of patients with prolactinoma who were treated with cabergoline for at least 12 months and in a group of control subjects recruited prospectively. We wish to evaluate the severity of regurgitation for the mitral, aortic, and tricuspid valves. Changes in cardiac valve apparatus was compared with treatment duration and cumulative cabergoline dose.
Detailed description
Within one week from a clinical observation in the outpatient service, all patients will be admitted to the hospital for a complete endocrine screening, a cardiological visit that will include an electrocardiogram and an echocardiogram.
The endocrine profile will include measurement of IGF-I, PRL, FSH, LH, 17-β-estradiol, testosterone, FT3, FT4, TSH, and cortisol at 8.00 in the morning after an overnight fasting.
The clinical profile will include blood pressure measurement at the right arm, with the subjects in relaxed sitting position. The average of six measurements (three taken by each of two examiners, in the same day of echocardiography, between 8.00-9.00 in the morning) with a mercury sphygmomanometer will be used in all analysis. According with the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (10), hypertension, if present, is classified as mild (Stage 1) when the SBP or DBP were between 140 and 159 mmHg and between 90 and 99 mmHg, respectively; severe (Stage 2) when the SBP or DBP were >160 and >100 mmHg respectively; pre-hypertension is defined as SBP >120¬ and <140 and DBP >80 and <90 mmHg. Heart rate will be also measured.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: CabergolinePatients already receiving treatment with cabergoline. |
| 2 | – | –healthy controls sex and age-matched with the patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Three different study populations will be studied. * Group 1) Patients already receiving treatment with cabergoline for at least 12 months * Group 2) Newly diagnosed patients with hyperprolactinemia who never received treatment with dopamine-agonists * Group 3) Non hyperprolactinemic subjects matched with the patients for sex and age to be used as controls.
Key inclusion criteria (2 listed)
- Patients with documented hyperprolactinemia receiving continuous treatment with cabergoline only for at least 12 months
- Newly diagnosed patients with prolactinoma never previously receiving dopamine agonists treatment
Key exclusion criteria (6 listed)
- A history of cardiac valve abnormalities,
- Previous use of anorectic drugs or other ergot-derived drugs,
- Treatment with cabergoline for less than 12 months,
- Valve calcification, valve regurgitation associated with annular dilatation or excessive leaflet motion,
- Mitral regurgitation associated with left ventricular wall-motion abnormalities or left ventricular dilatation,
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 |
|---|---|---|
| CabergolineAlso: DostinexAccording with our previous studies, in the patients with microprolactinoma and in those with non-tumoral hyperprolactinemia, cabergoline treatment was administered orally at a starting dose of 0.25 mg twice weekly for the first two weeks and then 0.5 mg twice weekly. After 2 months of treatment, dose adjustment was carried out every 2 months on the basis of serum PRL suppression. | Drug | 1 |
Primary outcome
Prevalence of regurgitation (graded as mild, moderate, severe) at any cardiac valve.
Time frame: 9 months
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 Apr 2008.
- Background: PubMed 12748199Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.
- Results publication: PubMed 16705142Gillam MP, Molitch ME, Lombardi G, Colao A. Advances in the treatment of prolactinomas. Endocr Rev. 2006 Aug;27(5):485-534. doi: 10.1210/er.2005-9998. Epub 2006 May 26.
- Results publication: PubMed 16148287Nutt JG, Wooten GF. Clinical practice. Diagnosis and initial management of Parkinson's disease. N Engl J Med. 2005 Sep 8;353(10):1021-7. doi: 10.1056/NEJMcp043908. No abstract available.
- Results publication: PubMed 12934784Flowers CM, Racoosin JA, Lu SL, Beitz JG. The US Food and Drug Administration's registry of patients with pergolide-associated valvular heart disease. Mayo Clin Proc. 2003 Jun;78(6):730-1. doi: 10.4065/78.6.730. No abstract available.
- Results publication: PubMed 15081648Van Camp G, Flamez A, Cosyns B, Weytjens C, Muyldermans L, Van Zandijcke M, De Sutter J, Santens P, Decoodt P, Moerman C, Schoors D. Treatment of Parkinson's disease with pergolide and relation to restrictive valvular heart disease. Lancet. 2004 Apr 10;363(9416):1179-83. doi: 10.1016/S0140-6736(04)15945-X.
- Results publication: PubMed 16267335Pinero A, Marcos-Alberca P, Fortes J. Cabergoline-related severe restrictive mitral regurgitation. N Engl J Med. 2005 Nov 3;353(18):1976-7. doi: 10.1056/NEJM200511033531822. No abstract available.
- Results publication: PubMed 12390688Serratrice J, Disdier P, Habib G, Viallet F, Weiller PJ. Fibrotic valvular heart disease subsequent to bromocriptine treatment. Cardiol Rev. 2002 Nov-Dec;10(6):334-6. doi: 10.1097/00045415-200211000-00005.
- Results publication: PubMed 17202453Schade R, Andersohn F, Suissa S, Haverkamp W, Garbe E. Dopamine agonists and the risk of cardiac-valve regurgitation. N Engl J Med. 2007 Jan 4;356(1):29-38. doi: 10.1056/NEJMoa062222.
- Results publication: PubMed 17202454Zanettini R, Antonini A, Gatto G, Gentile R, Tesei S, Pezzoli G. Valvular heart disease and the use of dopamine agonists for Parkinson's disease. N Engl J Med. 2007 Jan 4;356(1):39-46. doi: 10.1056/NEJMoa054830.
- Results publication: PubMed 11880025Botero M, Fuchs R, Paulus DA, Lind DS. Carcinoid heart disease: a case report and literature review. J Clin Anesth. 2002 Feb;14(1):57-63. doi: 10.1016/s0952-8180(01)00353-1.
- Results publication: PubMed 14627787Colao A, Di Sarno A, Cappabianca P, Di Somma C, Pivonello R, Lombardi G. Withdrawal of long-term cabergoline therapy for tumoral and nontumoral hyperprolactinemia. N Engl J Med. 2003 Nov 20;349(21):2023-33. doi: 10.1056/NEJMoa022657.
- Derived from this study: PubMed 23824978Auriemma RS, Pivonello R, Perone Y, Grasso LF, Ferreri L, Simeoli C, Iacuaniello D, Gasperi M, Colao A. Safety of long-term treatment with cabergoline on cardiac valve disease in patients with prolactinomas. Eur J Endocrinol. 2013 Aug 28;169(3):359-66. doi: 10.1530/EJE-13-0231. Print 2013 Sep.
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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.
Annamaria AL Colao, Prof. principal investigator
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prolactinomas, run by Federico II University at 1 site in Italy.
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 6 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 Apr 2008. 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 Italy. 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?
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?
Prevalence of regurgitation (graded as mild, moderate, severe) at any cardiac valve. (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00460616, which also lists 13 linked publications.
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 Apr 2008.