Current partner codePEPTIDESDE
NCT00234520·Not applicable·OBSERVATIONAL

A Study to Evaluate the Risk of Developing a Heart Condition Called Valvular Regurgitation in Patients With Acromegaly Treated With Either Lanreotide or Octreotide

Status

Completed

Phase

Not applicable

Enrollment

225

Locations

33

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

The aim of the study is to compare the risk of acromegaly patients developing valvular regurgitation when receiving lanreotide or octreotide

Interventions

Treatment arms and agents.

No intervention details reported.

Timeline

From registration to results.

  1. First posted

    Oct 7, 2005

  2. Study start

    May 2003

  3. Primary completion

    Feb 18, 2005

  4. Study completion

    Feb 18, 2005

  5. Results posted

    Not reported

  6. Registry updated

    Aug 2, 2019

Outcomes

What the study measures.

Primary outcomes

Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 12 months

Secondary outcomes

Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 6 months

Risk in each of the 4 valves at 6 & 12 months

Risk of significant regurgitation in each valve at 6 & 12 months

Prevalence of valvular regurgitation at baseline

Assessment of GH and IGF-1 levels at baseline, 6 months & 12 months

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Patient has a diagnosis of Acromegaly * Patient is being treated with lanreotide or octreotide in any dose form at the selection visit or is a de novo patient who is due to commence treatment within 2 weeks of baseline * Patient started treatment with either lanreotide or octreotide when both products were available on the market in their country * Patient must not change treatment form lanreotide to octreotide or vice versa for the duration of the study Exclusion Criteria: * Patients with known significant valve abnormalities prior to treatment with either lanreotide or octreotide * Patients who have received treatment with a somatostatin analogue other than lanreotide or octreotide for more than 3 months * Patients who have received treatment with a GH antagonist for more than 3 months * Patients who have had heart valve replacement therapy

Study locations

33 registered sites.

Belgium · Czechia · Denmark · France · Hungary · Italy · Poland · Spain · Sweden · United Kingdom. Showing up to 24 locations stored in the fast local snapshot.

Cliniques Universitaires Saint Luc

Brussels, Belgium

UZ Gasthuisberg

Leuven, Belgium

CHU de Liege

Liège, Belgium

University Hospital, Charles University

Kralove, Czechia

1st School of Medicine, Charles University

Prague, Czechia

National University Hospital

Copenhagen, Denmark

Hôpital de Bois

Bois-Guillaume, France

Hôpital de la Timone

Marseille, France

CHU de Brabois

Nancy, France

Centre Hospitalier Régional d'Orléans

Orléans, France

Hôpital du Haut-Lévêque

Pessac, France

Hôpital Maison Blanche

Reims, France

CHU de Rangueil

Toulouse, France

Semmelweis University Medical School

Budapest, Hungary

National Medical Center

Budapest, Hungary

Ospedali Riuniti di Bergamo

Bergamo, Italy

Università degli Studi di Ferrara

Ferrara, Italy

Dipartimento di Scienze, Endocrinologiche e Metaboliche

Genova, Italy

Università degli Studi di Milano

Milan, Italy

University "Federico II" of Naples

Naples, Italy

Clinica Medica II

Roma, Italy

Bielanski Hospital

Warsaw, Poland

Hospital General de Alicante

Alicante, Spain

Clínica Puerta de Hierro

Madrid, Spain

Related trials

More studies on Lanreotide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.